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Current Status of the
Bioresorbable Vascular Scaffold Where the Data Is Leading Us
David G. Rizik, M.D., F.A.C.C., F.S.C.A.I.
Chief Scientific Officer
Director of Structural & Coronary Interventions
HonorHealth and the Scottsdale-Lincoln HealthNetwork
Hon
orH
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Are Metallic DES More Forgiving?
Suboptimal Implant Technique
Courtesy Alok Sharma, MD
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13 Years Post Metallic DES Implant
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Spirit III Target Lesion
Failure @ 5 Years
Spirit IV Target Lesion
Failure @ 3 Years
Stone GW et al JACC 2011
2-3% per year late
hazard with DES
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BVS Distal Marker
BVS Proximal Marker
3.0 x 20 NC for pre-dil
3.0 x 28 mm BVS
3.5 x 20 NC for post-dil
2 years 4 years BVS 4-years Post Implant
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Everolimus-eluting Bioresorbable
Vascular Scaffolds in Patients with
Coronary Artery Disease:
The ABSORB III trial Dean J. Kereiakes, MD, Stephen G. Ellis, MD, D. Christopher
Metzger, MD, Ronald P. Caputo, MD, David G. Rizik, MD, Paul S. Teirstein, MD, Marc R. Litt, MD, Annapoorna Kini, MD, Ameer
Kabour, MD, Steven O. Marx, MD, Jeffrey J. Popma, MD, Robert McGreevy, PhD, Zhen Zhang, PhD, Charles Simonton, MD and
Gregg W. Stone, MD for the ABSORB III Investigators NEJM October, 2015
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1-Year TLF Components
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Device Thrombosis to 1 Year
Definite & Probable ST 1.53% vs 0.74%
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Outcomes by QCA RVD 2.25 mm
Thicker BVS struts may be of particular concern in small vessels
Eligibility: 2.50-3.75 mm
19% has a RVD < 2.25
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Absorb China Outcomes at 2 years:
All-cause death, MI, or revascularization for BVS vs.
Xience: 10.1% vs. 11.4%, p = 0.66
All-cause mortality: 0.4% vs. 2.5%, p = 0.12
MI: 3.0% vs. 2.1%, p = 0.56
Target lesion revascularization: 8.9% vs. 8.4%, p = 0.87
Scaffold thrombosis: 0.8% vs. 0%, p = 0.5 (very late
thrombosis: 0.4% vs. 0%)
*** Lowest rate of small vessels of RCTs
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Using OCT to Optimize BVS Result
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Take Home Message on PSP
A BVS-specific implantation strategy can improve outcomes
P PREPARE THE LESION S SIZE APPROPRIATELY P POST-DILATE
Why be meticulous in vessel preparation? Aids device delivery
Aids device expansion
Makes the PCI procedure easier
Sizing for BRS? Ameliorates the risk early events
Exclude small vessels (< 2.5 mm vessels)
Post dilation of BRS? Reduces the incidence of late events
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CO-96
Worldwide Absorb Voluntary Reporting of Thrombosis by Implant Date
0.00%
0.25%
0.50%
0.75%
1.00%
Implant Date
Thrombosis1
1. Data represents exponentially weighted moving average
Data/analysis not submitted or reviewed by FDA
2013 2014 2015
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ABSORB II Trial Results Key Clinical Outcomes By 4 Years
Proprietaryandconfidential— donotdistribute
ABSORB IIKey Clinical Outcomes by 4 Years
Absorb BVS(N=335)
XIENCE(N=166)
P-Value
3-4 Years TLF 1.0% (3) 0.7% (1) 1.00
Cardiac Death 0.3% (1) 0.7% (1) 0.54
TV-MI 0.3% (1) 0.0% (0) 1.00
ID-TLR 0.3% (1) 0.0% (0) 1.00
ST (Def/Prob) 0.0% (0) 0.0% (0) 1.00
0-4 Years TLF 11.5% (36) 6.0% (9) 0.06
Cardiac Death 1.3% (4) 2.7% (4) 0.28
TV-MI 7.3% (23) 1.3% (2) 0.008
ID-TLR 6.7% (21) 2.0% (3) 0.03
ST (Def/Prob) 3.0% (9) 0.0% (0) 0.03
Note:non-hierarchicalsummaryofthecomponentsofTLF
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ABSORB II 4-Year Results
Proprietaryandconfidential— donotdistribute
TL
F p
er
WH
O (
%)
0
5
10
15
20
25
Time Post Index Procedure (Days)
0 180 360 540 720 900 1080 1260 1440 1620
HR [95% CI]= 2.04 [0.98,4.24]
p=0.050 (Log rank test)
11.1%
5.6%
BVS XIENCE
0
5
10
15
20
25
1152 1260 1440 1620
HR [95% CI]= 1.44 [0.15,13.80]
p=0.75 (Log rank test)
1.0%0.7%
Δ = 0.3%
DoCE/TLF : Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)
ABSORB IITarget Lesion Failure (TLF)
Between 3 and 4 Years, (Once the Scaffold Disappears),
TLF Rate Was Comparable Between Absorb and XIENCE
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ABSORB II 4-Year Results
Proprietaryandconfidential— donotdistribute
AR
CS
T D
Pr
(%)
0
5
10
15
20
25
Time Post Index Procedure (Days)
0 180 360 540 720 900 1080 1260 1440 1620
HR [95% CI]= NA [NA]
p=0.033 (Log rank test)
2.8%
0.0%
BVS XIENCE
0
5
10
15
20
25
1152 1260 1440 1620
HR [95% CI]= NA [NA]
p= (Log rank test)
0.0%0.0%
No stent/scaffold thrombosis between 3 and 4 years”
ABSORB IIDefinite/Probable Scaffold/Stent Thrombosis
No Stent/Scaffold Thrombosis Between 3 and 4 Years Take home: Proposed a 30-50% (safe) reduction in resorption time.
Caveat: Don’t simply shift the time-to-event curves to the left (i.e. earlier time frame).
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ABSORB III Trial
Landmark Analysis 1 to 3 Years
Proprietaryandconfidential— donotdistribute
Target Lesion FailureLandmark Analysis
0%
5%
10%
15%
20%
25%
30%
0 6 12 18 24 30 36 42
5.7%7.5%
6.0%7.0%
No. at Risk:
Absorb
Xience
1322
686
1200
636
1145
603
1215
635
Time Post Procedure (Months)
HR [95% CI] =
1.33 [0.92, 1.92]
p=0.13 p=0.39
HR [95% CI] =
1.18 [0.81, 1.72]
0 – 1 Year 1 – 3 Years
Ta
rge
t le
sio
n f
ail
ure
(%
)
4.1%
3.2%
Absorb
XIENCE
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ABSORB III Trial Landmark Analysis
Proprietaryandconfidential— donotdistribute
Device ThrombosisLandmark Analysis
0%
1%
2%
3%
4%
5%
0 6 12 18 24 30 36 42
0.7%
1.5%
0.0%
0.8%0.3%
0.0%
No. at Risk:
Absorb
Xience
1322
686
1273
668
1211
634
1256
651
Time Post Procedure (Months)
De
vic
e t
hro
mb
os
is (
%)
Absorb
XIENCE
HR [95% CI] =
2.08 [0.78, 5.55]
p=0.13p=0.02
0 – 1 Year
1 – 3 Years
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ABSORB III at 2-3 Years Follow-up Impact of Technique
Proprietaryandconfidential— donotdistribute
ABSORB III 2-3 YearsTechnique
1.6%TLFrateforXIENCEinA-Japan:"OnlyforprimaryTLR.OnepatienthadaprimaryID-TLRonDay374andasecondaryID-TLRonDay1085
Several analyses have shown that these contemporary implant
techniques are associated with improved outcomes.
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HonorHealth Single Center Experience
169 Consecutive BVS Implants
• 169 BVS implants.
• > 90% underwent full P-S-P technique.
• > 90 % guided by high resolution imaging.
• Over 2/3 now have at least one year follow up.
• At present, there’s a single S.T.
• That patient was NOT loaded with DAPT until after the implant (acute ST less than an hour after implant).
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1. 73 y.o with high grade mid LAD disease.
2. Eccentric lesion.
3. Moderate calcium.
4. Diagonal side branch at lesion site
First U.S. Case Post FDA Approval
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1. Preservation of S.B.
2. Excellent apposition by OCT
Pre and Post Comparison
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50 year old patient with unstable angina.
Turned down for CABG and declined previous PCI.
Consented to complex PCI specifically for BVS.
Antegrade Wire Escalation Technique
3.0 x 20 NC Balloon for Pre-dilation
7 French Guideliner for Distal BVS Deployment
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3.0 x 28 BVS, 4.0 NC Balloon
3.5 x 28 BVS
4.0 NC Balloon
3.5 x 28 BVS
4.0 NC Balloon
4.0 x 15 Xience, 4.5 NC Balloon (based on OCT)
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Pre and post compare
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Plaque modification with R.A.
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Excellent apposition by OCT
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Parting Shots…
• ABSORB II, 4 year is the first RCT with data after the scaffold has been resorbed (full resorption is approximately 3 years).
• ABSORB II showed 0% ST between 3-4 years and TLF rate was comparable between Absorb to XIENCE, providing encouraging safety & efficacy results (the promise of BVS).
• No doubt the current device(s) need iteration.
• No doubt, adherence to technique is essential (i.e. P-S-P really works).
• Coronary intervention is a “skill game.”